A Phase III Study of an Otic Formulation in Acute Otitis Externa

NCT00750633 | Completed Phase 3 DMC

• 1 other identifier: C-07-13
• Study Type: interventional
• Target: 990
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).

Conditions

Acute Otitis Externa

Keywords

swimmer's ear; ear drops; ear infection; ear pain; ear inflammation

Outcome Measures

Primary Outcomes (2)

• Clinical Cure

  Day 3

• Clinical Cure

  Day 12

Secondary Outcomes (1)

• Microbiological Success

  Day 12

Study Arms (3)

Moxidex

EXPERIMENTAL

Moxidex otic solution

Drug: Moxidex otic solution; Device: Tympanostomy tubes

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin otic solution

Drug: Moxifloxacin otic solution; Device: Tympanostomy tubes

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone phosphate otic solution

Drug: Dexamethasone phosphate otic solution; Device: Tympanostomy tubes

Interventions

Moxidex otic solution DRUG

4 drops in the infected ear(s) twice daily (morning and evening) for 7 days

Moxidex

Moxifloxacin otic solution DRUG

4 drops in the infected ear(s) twice daily (morning and evening) for 7 days

Moxifloxacin

Dexamethasone phosphate otic solution DRUG

4 drops in the infected ear(s) twice daily (morning and evening) for 7 days

Dexamethasone

Tympanostomy tubes DEVICE

Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media with effusion in children

Dexamethasone; Moxidex; Moxifloxacin

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin
• A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema

You may not qualify if:

• Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks
• Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment
• Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa
• Known or suspected ear infection of fungal or mycobacterial origin
• Prior otologic surgery within 6 months of study entry
• Seborrheic dermatitis or other skin conditions of the external auditory canal
• Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis
• Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator
• Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study \[e.g., cleft palate (including repairs), Downs Syndrome, and cranial facial reconstruction\]
• Any current known or suspected infection (other than AOE) requiring systemic antimicrobial therapy
• Use of prohibited medications or inadequate washout of any medication listed in protocol
• Concomitant use of topical or oral analgesics (i.e., NSAIDs and aspirin products) which may have anti inflammatory effects. Patients on low dose aspirin therapy (81 mg per day) at the time of enrollment may be enrolled and continue the low dose aspirin during the study. Use of acetaminophen ("Tylenol") is permitted during the trial

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Otitis Externa; Otitis; Earache

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Contact Alcon Call Center

  1-888-451-3937

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 10, 2008
• Study Start: June 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 3, 2012

Record last verified: 2012-11